StrataPATH™ (Precision Indications for Approved Therapies)

Strata Oncology

Status and phase: Terminated; Phase 2

Conditions: Advanced Solid Tumor; Cancer

Treatments: Drug: enfortumab vedotin; Drug: talazoparib; Drug: axitinib; Drug: lorlatinib; Drug: sacituzumab govitecan; Drug: Fam-Trastuzumab Deruxtecan-Nxki; Drug: encorafenib + binimetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05097599

KEYNOTE-F04 (Other Identifier)

STR-004-001

Details and patient eligibility

About

StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations.

Full description

StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations. Aiming to increase clinical benefit for patients, this study will leverage technology advancements, scientific literature, and Strata's real-world evidence to define novel, highly responsive pan-tumor molecular indications for FDA-approved therapies in both the advanced and micro-metastatic settings. Strata will rapidly identify participants who have efficacy signals for possible expansion into adaptive or randomized studies. Enrollment in each drug/biomarker cohort is competitive. Cohorts may be added, changed, or discontinued over the course of the study

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

To be eligible to participate in this study, an individual must meet each of the criterion below and the criteria indicated in the selected biomarker/drug cohort appendix:

1. Male or female ≥18 years of age.
2. Pathologically confirmed solid tumor
3. Participants must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
4. CGP results need to be from a test conducted in a CLIA approved laboratory and archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue is required for confirmatory testing of non-Strata test results unless otherwise indicated within the cohort-specific protocol criteria.
5. Biomarker positive for the defined cohort
6. For individuals with non-primary, treated or stable brain metastases: No evidence of progression (defined as no radiographic evidence of progression) for at least 4 weeks prior to consent.
7. Adequate bone marrow, organ function & laboratory parameters as determined by the treating physician unless otherwise indicated within the cohort-specific protocol criteria.
8. Adequate cardiac function: 1) Left ventricular ejection fraction (LVEF) ≥ 50% and 2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred.

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Receiving another cancer treatment
2. Major surgery within 4 weeks prior to study entry
3. Has received a systemic cancer treatment within 3 weeks of first study dose
4. Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study principal investigator to determine eligibility.
5. Participant has primary central nervous system tumor.
6. A woman of childbearing potential who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
7. Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to use contraception for the duration of treatment.
8. Ongoing toxicity of CTCAE grade >2, other than peripheral neuropathy, related to anticancer therapy that was completed within 4 weeks of consent.
9. Ongoing peripheral neuropathy of CTCAE grade >3.
10. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 6 months of consent.
11. Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection.
12. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder.
13. Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 7 patient groups

Lorbrena® (lorlatinib)

Other group

Treatment:

Drug: lorlatinib

Braftovi® (encorafenib) + Mektovi® (binimetinib)

Other group

Treatment:

Drug: encorafenib + binimetinib

Talzenna® (talazoparib)

Other group

Treatment:

Drug: talazoparib

Trodelvy® (sacituzumab govitecan-hziy)

Other group

Treatment:

Drug: sacituzumab govitecan

Inlyta® (axitinib)

Other group

Treatment:

Drug: axitinib

Enhertu® (fam-trastuzumab deruxtecan-nxki)

Other group

Treatment:

Drug: Fam-Trastuzumab Deruxtecan-Nxki

Padcev® (enfortumab vedotin)

Other group

Treatment:

Drug: enfortumab vedotin